Category Archives: Gene Medicine

A new gene therapy that inhibits targeted nerve cell signaling effectively reduced neuropathic pain in mice with spinal cord or peripheral nerve injuries with no detectable side effects.

An international team of researchers led by scientists at the University of California San Diego School of Medicine reported that a gene therapy that inhibits targeted nerve cell signaling effectively reduced neuropathic pain in mice with spinal cord or peripheral nerve injuries with no detectable side effects.

The results, which were published in the online edition of Molecular Therapy on May 5, 2022, suggest a possible new treatment option for a condition that may affect more than half of individuals with spinal cord injuries. Neuropathy involves damage or dysfunction in nerves elsewhere in the body, typically resulting in chronic or debilitating numbness, tingling, muscle weakness, and pain.

There are no singularly effective remedies for neuropathy. Pharmaceutical therapy, for example, may need sophisticated, continuous medication administration and is linked with adverse side effects such as drowsiness and motor weakness. Opioids may be effective, but they can also develop tolerance and raise the risk of overuse or addiction.

Because physicians and researchers are able to pinpoint the precise location of a spinal cord injury and the origin of neuropathic pain, there has been much effort to develop treatments that selectively target impaired or damaged neurons in the affected spinal segments.

In recent years, gene therapy has proven an increasingly attractive possibility. In the latest study, researchers injected a harmless adeno-associated virus carrying a pair of transgenes that encode for gamma-aminobutyric acid or GABA into mice with sciatic nerve injuries and consequential neuropathic pain. GABA is a neurotransmitter that blocks impulses between nerve cells; in this case, pain signals.

The delivery and expression of the transgenes GAD65 and VGAT were restricted to the area of sciatic nerve injury in the mice and, as a result, there were no detectable side effects, such as motor weakness or loss of normal sensation. The production of GABA by the transgenes resulted in measurable inhibition of pain-signaling neurons in the mice, which persisted for at least 2.5 months after treatment.

Senior study author Martin Marsala, MD, is a professor in the Department of Anesthesiology at UC San Diego School of Medicine. Credit: UC San Diego Health Sciences

One of the prerequisites of a clinically acceptable antinociceptive (pain-blocking) therapy is minimal or no side effects like muscle weakness, general sedation or development of tolerance for the treatment, said senior author Martin Marsala, MD, professor in the Department of Anesthesiology in the UC San Diego School of Medicine.

A single treatment invention that provides long-lasting therapeutic effect is also highly desirable. These findings suggest a path forward on both.

Reference: Precision spinal gene delivery-induced functional switch in nociceptive neurons reverses neuropathic pain by Takahiro Tadokoro, Mariana Bravo-Hernandez, Kirill Agashkov, Yoshiomi Kobayashi, Oleksandr Platoshyn, Michael Navarro, Silvia Marsala, Atsushi Miyanohara, Tetsuya Yoshizumi, Michiko Shigyo, Volodymyr Krotov, Stefan Juhas, Jana Juhasova, Duong Nguyen, Helena Kupcova Skalnikova, Jan Motlik, Hana Studenovska, Vladimir Proks, Rajiv Reddy, Shawn P. Driscoll, Thomas D. Glenn, Taratorn Kemthong, Suchinda Malaivijitnond, Zoltan Tomori, Ivo Vanicky, Manabu Kakinohana, Samuel L. Pfaff, Joseph Ciacci, Pavel Belan and Martin Marsala, 5 May 2022, Molecular Therapy.DOI: 10.1016/j.ymthe.2022.04.023

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Gene Therapy Successfully Treats Spinal Cord Injuries Without Side Effects - SciTechDaily

image:In comparing the gene expression patterns of 26 species with diverse lifespans, University of Rochester biologists found that the characteristics of the different genes were controlled by circadian or pluripotency networks. view more

Credit: University of Rochester illustration / Julia Joshpe

Natural selection has produced mammals that age at dramatically different rates. Take, for example, naked mole rats and mice; the former can live up to 41 years, nearly ten times as long as similar-size rodents such as mice.

What accounts for longer lifespan? According to new research from biologists at theUniversity of Rochester, a key piece of the puzzle lies in the mechanisms that regulate gene expression.

In a paper published inCell Metabolism, the researchers, includingVera Gorbunova, the Doris Johns Cherry professor of biology and medicine;Andrei Seluanov, professor of biology and medicine; and Jinlong Lu, a postdoctoral research associate in Gorbunovas lab and the first author of the paper, investigated genes connected to lifespan. Their research uncovered specific characteristics of these genes and revealed that two regulatory systems controlling gene expressioncircadian and pluripotency networksare critical to longevity. The findings have implications both in understanding how longevity evolves and in providing new targets to combat aging and age-related diseases.

The researchers compared the gene expression patterns of 26 mammalian species with diverse maximum lifespans, from two years (shrews) to 41 years (naked mole rats). They identified thousands of genes related to a species maximum lifespan that were either positively or negatively correlated with longevity.

They found that long-lived species tend to have low expression of genes involved in energy metabolism and inflammation; and high expression of genes involved in DNA repair, RNA transport, and organization of cellular skeleton (or microtubules). Previous research by Gorbunova and Seluanov has shown that features such asmore efficient DNA repairand aweaker inflammatory responseare characteristic of mammals with long lifespans.

The opposite was true for short-lived species, which tended to have high expression of genes involved in energy metabolism and inflammation and low expression of genes involved in DNA repair, RNA transport, and microtubule organization.

When the researchers analyzed the mechanisms that regulate expression of these genes, they found two major systems at play. The negative lifespan genesthose involved in energy metabolism and inflammationare controlled by circadian networks. That is, their expression is limited to a particular time of day, which may help limit the overall expression of the genes in long-lived species.

This means we can exercise at least some control over the negative lifespan genes.

To live longer, we have to maintain healthy sleep schedules and avoid exposure to light at night as it may increase the expression of the negative lifespan genes, Gorbunova says.

On the other hand, positive lifespan genesthose involved in DNA repair, RNA transport, and microtubulesare controlled by what is called the pluripotency network. The pluripotency network is involved in reprogramming somatic cellsany cells that are not reproductive cellsinto embryonic cells, which can more readily rejuvenate and regenerate, by repackaging DNA that becomes disorganized as we age.

We discovered that evolution has activated the pluripotency network to achieve longer lifespan, Gorbunova says.

The pluripotency network and its relationship to positive lifespan genes is therefore an important finding for understanding how longevity evolves, Seluanov says. Furthermore, it can pave the way for new antiaging interventions that activate the key positive lifespan genes. We would expect that successful antiaging interventions would include increasing the expression of the positive lifespan genes and decreasing the expression of negative lifespan genes.

Comparative transcriptomics reveals circadian and pluripotency networks as two pillars of longevity regulation

16-May-2022

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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The secret to a longer lifespan? Gene regulation holds a clue - EurekAlert

BURLINGTON, N.C.--(BUSINESS WIRE)--Labcorp (NYSE: LH), a leading global life sciences company, understands the important and growing role of precision medicine and is working to ensure more people have access to targeted and personalized treatments. As part of this effort, the company is announcing a new sponsored testing program aimed at helping advanced non-small cell lung (NSCLC) cancer patients and their physicians make informed treatment and care management decisions through comprehensive genomic insights.

The new program is sponsored by Eli Lilly and Company, a global health care leader dedicated to developing and delivering innovative new medicines to make a meaningful difference in the lives of cancer patients. The program will use Labcorps OmniSeq INSIGHTSM test, a pan-cancer, tissue-based sequencing test, to provide comprehensive genomic and immune profiling for cases that meet eligibility criteria. The program is designed to increase awareness of and provide enhanced access to more comprehensive testing options for eligible NSCLC patients in order to encompass all indicated guideline-directed genes and biomarkers.

Comprehensive genomic and immune profiling allows for a much more extensive investigation into biomarkers that can lead to more effective treatment options, access to new clinical trials, and better patient outcomes, said Prasanth Reddy, M.D., MPH, senior vice president and oncology head at Labcorp. With OmniSeq INSIGHT testing, people across the country living with lung cancer may be able to receive therapies or be informed of clinical trials that otherwise may not have been available because their specific biomarkers or gene mutations were not found in a single gene test. By equipping oncologists, health care systems and pharmaceutical developers with data-driven insights we are bringing the promise of precision medicine within reach for all.

Comprehensive genomic profiling (CGP) allows physicians to test for all actionable biomarkers that may be present in patients with NSCLC, rather than one or a few biomarkers that can be found using single gene testing. Comprehensive immune profiling tests for immune-related genes to provide novel, differentiating insights into the tumor microenvironment by testing for immune-related genes. These insights help identify potential immunotherapy eligibility. Test results from both genomic and immune profiling are used to help inform oncologists of the most appropriate targeted therapy for their patients.

Comprehensive genomic profiling helps identify treatment options for patients to better inform targeted therapy selection, said Anthony (Nino) Sireci, M.D., vice president clinical biomarker and diagnostics development, Loxo Oncology at Lilly. Our collaboration with Labcorp in their efforts to deliver OmniSeq INSIGHT tests to more patients further demonstrates the value of precision medicine and our commitment to making a difference.

Labcorp Oncology is committed to pioneering scientific breakthroughs that make a difference in cancer care through investments in innovative programs such as OmniSeq INSIGHT. OmniSeq INSIGHT is a pan-cancer, solid tumor test that combines two different treatment paradigmsgenomic and immune profiling. The test enhances the characterization of the unique genomic biomarkers in a patients tumor enabling clinicians to make more informed decisions about personalized treatment approaches that can be more effective and may have fewer side effects, in addition to identifying clinical trials for which patients may be eligible.

Click here to learn more.

About Labcorp

Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With more than 75,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $16 billion in FY2021. Learn about Labcorp at http://www.Labcorp.com, or follow us on LinkedIn and Twitter @Labcorp.

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Labcorp Expands Access to Comprehensive Genomic Testing Through New Lung Cancer Program - Business Wire

According to a new report published by Grand View Research, Recent advancements in biological therapies have resulted in a gradual shift in preference toward personalized medicinal strategies over the conventional treatment approach. This has resulted in rising R&D activities in the regenerative medicine arena for the development of novel regenerative therapies.

Regenerative Medicine Industry Overview

The global regenerative medicine market size was valued at USD 27.29 billion in 2020 and is expected to reach USD 57.08 billion by 2027, growing at a CAGR of 11.27% over the forecast period. The emergence of gene therapy coupled with the developments in stem cell and tissue engineering are expected to fuel the market growth. In addition, increasing regulatory approvals for advanced therapy medicinal products have propelled the market growth. The ongoing COVID-19 pandemic created lucrative opportunities for the operating players owing to the urgent need for the development of new therapies against SARS-COV-2. Several initiatives are being implemented in the cell and gene therapy manufacturing industry, including the T-cell therapy space.

For instance, based on the previous research insights, Singapore-based Duke-NUS medical schools emerging infectious diseases research program demonstrated the utility of these immunotherapies in treating patients with COVID-19 infection. The presence of several programs and continuous investments by government and private agencies to support R&D also accelerate the industrys progress. Like National Institutes of Health (NIH) supports the scientific research community through NIH Regenerative Medicine Program, NIH Stem Cell Libraries & Projects, NIH Stem Cell Unit, and others. Similarly, initiatives adopted by market players to raise finance for the R&D of regenerative medicine support the market progression.

Gather more insights about the market drivers, restrains and growth of the Global Regenerative Medicine market

In addition, companies are collaborating to strengthen their R&D capabilities to develop and commercialize innovative therapies to ensure their availability to their customers locally or worldwide. For instance, in July 2021, Pharming Group N.V. and Orchard Therapeutics collaborated for the development and commercialization of OTL-105, an investigational ex vivo autologous Hematopoietic Stem Cell (HSC) gene therapy for the treatment of Hereditary Angioedema (HAE).

Moreover, technological advancements in stem cell-based therapies have revolutionized the perspective of researchers toward regenerative medicine. Advances in stem cell therapy have accelerated the developments in regenerative medicine. For instance, haematogenic stem cells currently are being used to treat leukemia and blood disorders. Also, nanotechnology is a powerful tool for engineering stem cells and regenerative medicine. With the introduction of new technology, nanofabrication techniques can now allow researchers to develop nanofiber scaffolds.

Regenerative Medicine Market Segmentation

Based on the Product Insights, the market is segmented into Therapeutics, Tools, Banks, and Services.

Based on the Therapeutic Category Insights, the market is segmented into Dermatology, Musculoskeletal, Immunology & Inflammation, Oncology, Cardiovascular, Ophthalmology, and Others.

Based on the Regenerative Medicine Regional Insights, the market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Market Share Insights:

Key Companies Profile:

Key companies invest heavily in the development of regenerative therapies to meet the demand for unmet clinical needs. The market is highly competitive as the companies are focusing on the introduction of therapies for oncology & age-related degenerative disorders.

Some of the prominent companies in the global regenerative medicine market are:

Order a free sample PDF of the Regenerative Medicine Market Intelligence Study, published by Grand View Research.

About Grand View Research

Grand View Research is a full-time market research and consulting company registered in San Francisco, California. The company fully offers market reports, both customized and syndicates, based on intense data analysis. It also offers consulting services to business communities and academic institutions and helps them understand the global and business scenario to a significant extent. The company operates across multitude of domains such as Chemicals, Materials, Food and Beverages, Consumer Goods, Healthcare, and Information Technology to offer consulting services.

Web: https://www.grandviewresearch.com

Media ContactCompany Name: Grand View Research, Inc.Contact Person: Sherry James, Corporate Sales Specialist U.S.A.Email: Send EmailPhone: 1888202951Address:Grand View Research, Inc. 201 Spear Street 1100 San Francisco, CA 94105, United StatesCity: San FranciscoState: CaliforniaCountry: United StatesWebsite: https://www.grandviewresearch.com/industry-analysis/regenerative-medicine-market

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Regenerative Medicine Market To Grow At A CAGR Of 11.27% By 2027, Due To Advancements In Cell Biology, Genomics Research, And Gene-Editing Technology...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced its participation in a neoadjuvant screening trial in partnership with the Lung Cancer Research Foundation (LCRF) and Lung Cancer Mutation Consortium (LCMC). This screening trial, entitled LCMC4 Evaluation of Actionable Drivers in EaRly Stage Lung Cancer (LEADER), is the fourth study conducted through the LCMC and is a collaborative effort involving numerous academic study sites and pharmaceutical supporters. Foundation Medicine will be the sole provider of comprehensive genomic profiling (CGP) in the LEADER trial, which will utilize both of Foundation Medicines FDA-approved CGP tests: the tissue-based FoundationOneCDx and the blood-based FoundationOneLiquid CDx.

The LEADER trial is utilizing an umbrella trial design to screen for 11 actionable driver mutations in 1,000 patients with high-risk, resectable non-small cell lung cancer (NSCLC). These patients are candidates for neoadjuvant therapy, which is treatment given as a first step to shrink a tumor before the main treatment, often surgery. By identifying patients with biomarker-positive tumors for enrollment to several matched therapeutic trials, the LEADER trial aims to develop essential data that can be used to support oncologists in their personalized treatment planning for cancer patients prior to such patients undergoing surgery.

The neoadjuvant setting is a rapidly evolving space for the development of precision treatment options in lung cancer. Enabling trials in this setting will continue to help us understand the impact of targeted therapies in the curative treatment of NSCLC, says Dr. Geoff Oxnard, Foundation Medicines VP, Head of Clinical Development. At Foundation Medicine, we are committed to being an engaged collaborator in the pivotal research needed to shape the future of cancer care for patients at all stages, so that patients can get on the right therapy at the right time for their specific cancer.

The results from both FoundationOne CDx and FoundationOne LiquidCDx will be used by LEADER trial sites to screen patients for actionable driver mutations. While circulating tumor DNA (ctDNA) shed is often lower in early disease, the goal of using both tests in the LEADER trial is to help researchers understand how blood-based CGP testing can complement tissue-based CGP testing to inform targeted treatment in resectable NSCLC.

In the past two years, the FDA has granted approvals for the first tyrosine kinase inhibitor and checkpoint inhibitor, respectively, for the adjuvant treatment of resected NSCLC, each requiring testing for precision biomarkers. The FDA has also recently granted approval for neoadjuvant immunotherapy for resectable NSCLC, as well as the first-and-only immunotherapy-based treatment for neoadjuvant use in NSCLC, reinforcing the value of targeted therapies as a component of curative lung cancer. These FDA approvals could better position early-stage NSCLC patients, like those who are enrolled in the LEADER trial, to become potential candidates for these personalized treatment approaches.

The LEADER trial is now open to enrollment and will include participation from trial sites and investigators across the oncology community, including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Dana Farber Cancer Institute, Yale Cancer Center/Smilow Cancer Hospital and many others.

In a new Trial in Progress abstract being presented at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting from June 3-7, Boris Sepesi, M.D., associate professor of Thoracic and Cardiovascular Surgery at The University of Texas MD Anderson Cancer Center, and principal investigator of the LEADER Trial, and Mark Kris, M.D., Attending Physician, Thoracic Oncology Service, Department of Medicine at Memorial Sloan Kettering Cancer Center will detail LEADERs primary objective of determining the proportion of resectable NSCLC patients within the trial who possess actionable oncogenic drivers. Results from Foundation Medicine CGP testing will inform the LEADER trial sites on their selection of neoadjuvant therapy and enrollment onto independent therapeutic trials with genomically matched neoadjuvant treatment, standard therapies or other trials if no driver is detected. Read more on ASCO.org, and visit Foundation Medicine at Booth #13019 to learn more. Follow along on Twitter and LinkedIn for more details about Foundation Medicines data being presented at ASCO22.

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on http://www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

About FoundationOneCDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

About FoundationOneLiquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit http://www.F1LCDxLabel.com.

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

Source: Foundation Medicine

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Foundation Medicine Partners with Lung Cancer Research Foundation and the Lung Cancer Mutation Consortium on Screening Trial to Enable Precision...

BOSTON & ZUG, Switzerland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (NASDAQ: CRSP) today announced new late-breaking clinical data accepted for oral presentation at the 2022 European Hematology Association (EHA) Congress. Vertex also announced three abstracts accepted for poster presentation at EHA.

Late-breaking abstract #LB2367 entitled Efficacy and Safety of A Single Dose of CTX001 For Transfusion-Dependent eta-Thalassemia and Severe Sickle Cell Disease, will be an oral presentation on Sunday, June 12 at 09:4511:15 CEST. The abstract from Vertex and CRISPR Therapeutics includes data on patients treated in CLIMB111 and CLIMB121 and followed in CLIMB131 with CTX001, now known as exagamglogene autotemcel (exa-cel). This abstract has been selected for the media briefing program and is therefore embargoed until Saturday, June 11 at 09:00 am CEST.

In addition, three real-world evidence and health economics abstracts from Vertex have been accepted for poster presentation.

The accepted abstracts are now available online on the EHA website.

Exacel is being investigated in multiple ongoing clinical trials as a potential one-time therapy for patients with either TDT or SCD.

About exagamglogene autotemcel (exa-cel)

Exacel, formerly known as CTX001, is an investigational, autologous, ex vivo CRISPR/Cas9 geneedited therapy that is being evaluated for patients with TDT or SCD characterized by recurrent VOCs, in which a patients own hematopoietic stem cells are edited to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygencarrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. The elevation of HbF by exacel has the potential to alleviate transfusion requirements for patients with TDT and reduce painful and debilitating sickle crises for patients with SCD. Earlier results from these ongoing trials were published in The New England Journal of Medicine in January of 2021.

Based on progress in this program to date, exacel has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for both TDT and SCD. Exa-cel has also been granted Orphan Drug Designation from the European Commission, as well as Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), for both TDT and SCD.

Among geneediting approaches being evaluated for TDT and SCD, exacel is the furthest advanced in clinical development.

About CLIMB111 and CLIMB121

The ongoing Phase 1/2/3 openlabel trials, CLIMB111 and CLIMB121, are designed to assess the safety and efficacy of a single dose of exacel in patients ages 12 to 35 years with TDT or with SCD, characterized by recurrent VOCs, respectively. The trials are now closed for enrollment. Patients will be followed for approximately two years after exacel infusion. Each patient will be asked to participate in CLIMB131, a longterm followup trial.

About CLIMB-131

This is a longterm, openlabel trial to evaluate the safety and efficacy of exacel in patients who received exacel in CLIMB111, CLIMB121, CLIMB141 or CLIMB151. The trial is designed to follow participants for up to 15 years after exacel infusion.

About CLIMB141 and CLIMB151

The ongoing Phase 3 open-label trials, CLIMB141 and CLIMB151, are designed to assess the safety and efficacy of a single dose of exacel in patients ages 2 to 11 years with TDT or with SCD, characterized by recurrent VOCs, respectively. The trials are now open for enrollment and currently enrolling patients ages 5 to 11 years of age and will plan to extend to ages 2 to less than 5 years of age at a later date. Each trial will enroll up to 12 patients. Patients will be followed for approximately two years after infusion. Each patient will be asked to participate in CLIMB-131, a longterm followup trial.

About the GeneEditing Process in These Trials

Patients who enroll in these trials will have their own hematopoietic stem and progenitor cells collected from peripheral blood. The patients cells will be edited using the CRISPR/Cas9 technology. The edited cells, exacel, will then be infused back into the patient as part of an autologous hematopoietic stem cell transplant (HSCT), a process which involves a patient being treated with myeloablative busulfan conditioning. Patients undergoing HSCT may also encounter side effects (ranging from mild to severe) that are unrelated to the administration of exacel. Patients will initially be monitored to determine when the edited cells begin to produce mature blood cells, a process known as engraftment. After engraftment, patients will continue to be monitored to track the impact of exacel on multiple measures of disease and for safety.

About the VertexCRISPR Collaboration

Vertex and CRISPR Therapeutics entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. Exacel represents the first potential treatment to emerge from the joint research program. Under an amended collaboration agreement, Vertex now leads global development, manufacturing and commercialization of exacel and splits program costs and profits worldwide 60/40 with CRISPR Therapeutics.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) a rare, life-threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1mediated kidney disease, pain, type 1 diabetes, alpha1 antitrypsin deficiency and Duchenne muscular dystrophy.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 12 consecutive years on Science magazine's Top Employers list and one of the 2021 Seramount (formerly Working Mother Media) 100 Best Companies. For company updates and to learn more about Vertex's history of innovation, visit http://www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

(VRTX-GEN)

Vertex Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our plans and expectations to present clinical data from the ongoing exa-cel clinical trials during the EHA Congress, expectations regarding the abstracts that will be made available on the virtual platform and the clinical data that will be presented during the EHA Congress, including anticipated projections and estimates related to the various economic impacts of SCD and TDT, the potential benefits, efficacy, and safety of exa-cel, including the potentially transformative nature of the therapy and the potential of the treatment for patients, our plans and expectations for our clinical trials and pipeline products, the status of our clinical trials of our product candidates under development by us and our collaborators, including activities at the clinical trial sites, patient enrollment and expectations regarding clinical trial follow-up. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from a limited number of patients may not be indicative of final clinical trial results, that data from the company's development programs, including its programs with its collaborators, may not support registration or further development of its compounds due to safety and/or efficacy, or other reasons, that internal or external factors that could delay, divert, or change our plans and objectives with respect to our research and development programs, that future competitive or other market factors may adversely affect the commercial potential for exa-cel, and other risks listed under the heading Risk Factors in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission (SEC) and available through the company's website at http://www.vrtx.com and on the SECs website at http://www.sec.gov. You should not place undue reliance on these statements or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(CRSP-GEN)

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit http://www.crisprtx.com.

CRISPR Therapeutics Forward-Looking Statement

This press release may contain a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, as well as statements regarding CRISPR Therapeutics expectations about any or all of the following: i) the safety, efficacy and clinical progress of the ongoing exa-cel clinical trials, including expectations regarding the abstract that will be made available on the virtual platform and our plans to present and the clinical data that are being presented during the EHA Congress; and (ii) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. Without limiting the foregoing, the words believes, anticipates, plans, expects and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, existing and prospective investors are cautioned that forward-looking statements are inherently uncertain, are neither promises nor guarantees and not to place undue reliance on such statements, which speak only as of the date they are made. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the potential for initial and preliminary data from any clinical trial and initial data from a limited number of patients (as is the case with exa-cel at this time) not to be indicative of final or future trial results; the potential that the exa-cel clinical trial results may not be favorable or may not support registration or further development; that future competitive or other market factors may adversely affect the commercial potential for exa-cel; CRISPR Therapeutics may not realize the potential benefits of its collaboration with Vertex; potential impacts due to the coronavirus pandemic, such as to the timing and progress of clinical trials; uncertainties regarding the intellectual property protection for CRISPR Therapeutics technology and intellectual property belonging to third parties; and those risks and uncertainties described under the heading Risk Factors in CRISPR Therapeutics most recent annual report on Form 10-K, quarterly report on Form 10-Q, and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC's website at http://www.sec.gov. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

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Vertex and CRISPR Therapeutics Announce Acceptance of Late-Breaking Abstract for CTX001 at the 2022 Annual European Hematology Association (EHA)...

image:A P01 program project grant from the National Cancer Institute will provide nearly $11 million dollars over five years to a team of Winship researchers led by Haian Fu, PhD, (left) and Suresh Ramalingam, MD. view more

Credit: Winship Cancer Institute

Atlanta, Georgia (June 1, 2022) Winship Cancer Institute of Emory University has been awarded a P01 program project grant from the National Cancer Institute (NCI) to support research aimed at improving the effectiveness of immunotherapy for lung cancer in patients with a mutation of the LKB1 gene, a group for whom the present immunotherapy options do not provide robust benefit. The award will provide nearly $11 million dollars over 5 years to a team of Winship researchers led by Haian Fu, PhD, and Suresh Ramalingam, MD.

Approximately 250,000 new cases of lung cancer are diagnosed each year in the United States. More than 60% of these patients present with advanced stage disease, rendering them unable to benefit from curative treatment approaches, such as surgery, stereotactic radiosurgery and radiation therapy. Because advanced stage disease is more difficult to treat, the five-year survival rate is only about 15% in the US, and even less worldwide.

The most common type of lung cancer is non-small cell lung cancer (NSCLC), which accounts for about 85% of cases, and half of NSCLC cases are lung adenocarcinoma (LUAD). Despite a decline in lung cancer incidence overall, the incidence of LUAD has been on the rise for the past few decades, posing an increased therapeutic challenge and urgent medical needs.

Major scientific and clinical advances have led to personalized therapies tailored to the tumors genomic background and immunotherapies that target the immune system. Immunotherapies such as immune checkpoint inhibitors have revolutionized the treatment of cancer, including LUAD. Immune checkpoint inhibitors enable immune cells to attack tumor cells by blocking immune checkpoints from preventing an anticancer response. However, the innate and acquired resistance of tumors to the current generation of immune checkpoint inhibitors poses a major challenge for broad clinical gains.

In approximately 20% of patients with LUAD, the LKB1 gene is mutated (a mutation is a change in the DNA sequence of genes that causes cancer cells to grow and spread). While it is unclear what causes the mutation, it has been linked with lack of response to immunotherapy.

The P01 grant will help to understand the reasons behind resistance to immunotherapy in patients with LKB1 mutation and seek to develop novel treatment approaches to improve efficacy, says the program projects principal investigator, Haian Fu, leader of Winships Discovery and Developmental Therapeutics Program, the Winship Partner in Research Endowed Chair and professor and chair of the Department of Pharmacology and Chemical Biology at the Emory University School of Medicine. Specifically, we will examine the intricate interplay between LKB1-mutant status and cancer metabolism, immunity and invasion to gain mechanistic insights needed to accelerate conceptual advances.

Fu and a team of Winship researchers will lead three integrated projects aimed at first understanding the role of LKB1 mutations and LUADs resistance to immune checkpoint inhibitors and then translating these insights into a clinical trial testing new anti-cancer therapeutic strategies to overcome immunotherapy resistance.

Despite the success of immunotherapy, its long-term benefits are limited to only 20% of patients with lung cancer; so extending the benefits to broader patient populations is a goal for our researchers, says principal investigator of the project and Winships executive director, Suresh Ramalingam, who also is the Roberto C. Goizueta Distinguished Chair for Cancer Research and a professor of hematology and medical oncology at the Emory University School of Medicine. Improving the effectiveness of immunotherapy for patients with LKB1 mutation will have a major impact on lung cancer outcomes.

The Winship lung cancer P01 program team project and core leaders include Winship members Sumin Kang, PhD, associate professor in the Emory Department of Hematology and Medical Oncology; Kavita Dhodapkar, MBBS, professor in the Emory Department of Pediatrics and director of the Pediatric Immuno-Oncology Program at the Aflac Cancer and Blood Disorders Center; Madhav Dhodapkar, MBBS, leader of Winships Cancer Immunology Research Program, director of Winships Center for Cancer Immunology, professor and Anise McDaniel Brock Chair in the Emory Department of Hematology and Medical Oncology; Adam Marcus, PhD, Winships deputy director, scientific director of Winships Integrated Cellular Imaging Shared Resource and Winship 5K Research Professor in the Emory Department of Hematology and Medical Oncology; Wei Zhou, PhD, leader of Winships Cell and Molecular Biology Research Program and professor in the Emory Department of Hematology and Medical Oncology; Frank Schneider, MD, director of Winships Cancer Tissue and Pathology Shared Resource and associate professor in the Emory Department of Pathology and Laboratory Medicine; Yuan Liu, PhD, MS, research associate professor in Winships Biostatistics Shared Resource and in the Emory Department of Biostatistics and Bioinformatics; Madhusmita Behera, PhD, Winship chief informatics and data officer and director of the Winship Data and Technology Applications; and Andrey Ivanov, PhD, assistant professor in the Emory Department of Pharmacology and Chemical Biology.

About Winship Cancer Institute of Emory University

As the only National Cancer Institute-designated Comprehensive Cancer Center for the state of Georgia, Winship Cancer Institute of Emory University discovers, develops, delivers and teaches some of the worlds most effective ways to prevent, detect, diagnose and treat each patients unique cancer. Winship leverages the depth and breadth of Emory University and collaborates with other NCI-designated Cancer Centers and leading cancer organizations to advance cancer science and care. Winship has more than 500 faculty members who together received $80 million in cancer research funding in 2020, $33 million of that from NCI. Also, in 2020, Winship enrolled more than 900 patients and volunteers in its 300 cancer clinical trials. For more information, visit winshipcancer.emory.edu

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Winship receives $11 million grant from the National Cancer Institute to improve immunotherapy for lung cancer - EurekAlert

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Clin Chem. 2022 Jun 2:hvac073. doi: 10.1093/clinchem/hvac073. Online ahead of print.

ABSTRACT

BACKGROUND: Revealing molecular mechanisms linked to androgen receptor activity can help to improve diagnosis and treatment of prostate cancer. Retinoic acid-induced 2 (RAI2) protein is thought to act as a transcriptional coregulator involved in hormonal responses and epithelial differentiation. We evaluated the clinical relevance and biological function of the RAI2 protein in prostate cancer.

METHODS: We assessed RAI2 gene expression in the Cancer Genome Atlas prostate adenocarcinoma PanCancer cohort and protein expression in primary tumors (n = 199) by immunohistochemistry. We studied RAI2 gene expression as part of a multimarker panel in an enriched circulating tumor cell population isolated from blood samples (n = 38) of patients with metastatic prostate cancer. In prostate cancer cell lines, we analyzed the consequences of androgen receptor inhibition on RAI2 protein expression and the consequences of RAI2 depletion on the expression of the androgen receptor and selected target genes.

RESULTS: Abundance of the RAI2 protein in adenocarcinomas correlated with the androgen receptor; keratins 8, 18, and 19; and E-cadherin as well as with an early biochemical recurrence. In circulating tumor cells, detection of RAI2 mRNA significantly correlated with gene expression of FOLH1, KLK3, RAI2, AR, and AR-V7. In VCaP and LNCaP cell lines, sustained inhibition of hormone receptor activity induced the RAI2 protein, whereas RAI2 depletion augmented the expression of MME, STEAP4, and WIPI1.

CONCLUSIONS: The RAI2 protein functions as a transcriptional coregulator of the androgen response in prostate cancer cells. Detection of RAI2 gene expression in blood samples from patients with metastatic prostate cancer indicated the presence of circulating tumor cells.

PMID:35652463 | DOI:10.1093/clinchem/hvac073

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Expression Patterns and Corepressor Function of Retinoic Acid-induced 2 in Prostate Cancer - DocWire News

SAN DIEGO, June 2, 2022 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced the acceptance of seven key oncology research abstracts authored in collaboration with Illumina at the American Society of Clinical Oncology (ASCO) annual meeting taking place June 3 June 7 in Chicago. In addition, Illumina will host a related event, "Unlocking Precision Medicine: The Transformational Impact of Comprehensive Genomic Profiling," featuring Chief Medical Officer, Phil Febbo, MD; Kevin Keegan, Vice President and General Manager, Oncology; and a panel of leading oncologists from select community and academic programs.

"At Illumina, we are seeingincreased adoption of comprehensive genomic profiling in both in-house pathology labs and centralized labs to inform and enhance patient care," said Keegan. "Through our involvement in this year's ASCO, we look forward to learning more about and exploring the comprehensive genomic profiling experiences of leading oncology researchers to help inform this important work moving forward."

Illumina's mission in oncology is to save lives by enabling personalized cancer care through genomics. This includes increasing enablement for pathology labs to perform comprehensive genomic profiling for cancer tumors.

Comprehensive genomic profiling is a next-generation sequencing (NGS) approach that uses a single test to assess hundreds of genes including relevant cancer biomarkers, as established in medical guidelines and clinical trials, for solid tumor therapy guidance. CGP is being increasingly adopted by pathologists and oncologists to enhance their abilities to identify actionable biomarkers, which can lead to better matches between patients and precision therapies and clinical trials.Studies show that patients who receive a genomic match to biomarker-driven targeted therapies or immunotherapies experience improved clinical outcomes.

"For a physician, the priority is finding the best course of therapy for the patient as quickly as possible," said Dr. Febbo. "With a rapidly growing catalogue of targeted drugs and immunotherapies for many cancer types we are increasingly able to prescribe more and more personalized treatments. In addition, pan cancer markers identify an important group of patients that benefit from targeted therapy regardless of their tumor's tissue of origin."

Abstracts accepted at ASCO

Collaborations across the oncology field are vital to increasing clinical utility evidence for comprehensive genomic profiling (CGP). Illumina is proud to present the following results of joint studies at ASCO:

Identification of Clinically Actionable Biomarkers via Routine CGP Across a Large Community Health System,is an abstract summarizing data from a joint study between Illumina and Providence Health System. The results show the improvement inidentification of clinically actionable biomarkers via routine CGP versus conventional testing methods (clinical actionability: 45% CGP vs. 19% small panel, p

Pathogenic fusion detection in solid malignancies utilizing RNA-DNA based CGP testingis a poster presentation, also a result of the collaboration between Illumina and Providence Health System. The results show that the 523-gene, combined DNA and RNA assay used at Providence Health System identified actionable fusion targets across tumor types in 7% (N=216) of patients. Of the patients with pathogenic fusions, 29% were actionable to a targeted therapy, and 31% eligible for 1 of 3 basket clinical trials.Conventional testing methods, namely FISH and DNA-only targeted panels, have technical limitations that prevent the detection of all relevant fusion partners. This potentially leads to false negatives, which would leave these patients without eligibility to highly effective therapies in absence of a combined DNA- and RNA-based CGP assay.

Blood-based CGP analysis is an emerging area of growth and interest as a complement to tissue-based tumor profiling or other alternatives when tissue is unavailable. In a poster session at ASCO, The National Cancer Institute will present data generated in collaboration with Illumina. The abstract is entitledBlood-based detection of actionable alterations from NCI-MATCH patients with no tissue results. As part of The Molecular Analysis for Therapy Choice (NCI-MATCH) study, it evaluatedtheblood-based detection of actionable alterations from NCI-MATCH patients with no tissue results. Pathologists observed variants in the blood samples consistent with what was reported in tumor tissue samples from the larger NCI-MATCH study cohort. Using liquid biopsy provided valuable mutation information for these patients and could have resulted in up to an additional 75 patients being eligible for treatment selection based on their mutation profile.

In addition to these, the following abstracts, authored in collaboration with Illumina, will be published.

Effective biomarker testing rates in a large U.S. oncology practice-Abstract presents data from real-world clinical utility study of CGP testing with Florida Cancer Specialists & Research Institute.

Assessing homologous recombination deficiency (HRD) in ovarian cancer- Optimizing concordance of the regulatory-approved companion diagnostic and a next-generation sequencing (NGS) assay kit-Study data resulting from collaboration with Institute of Pathology, Technical University of Munich, Merck, AstraZeneca and Myriad Genetics.

Prototype precision oncology learning ecosystem: Norwegian precision cancer medicine implementation initiative-Data resulting from national CGP trial in Norway - IMPRESS (Improving public cancer care by implementing precision medicine in Norway).

Actionability of comprehensive genomic profiling (CGP) compared to single-gene and small panels in patients with advanced/metastatic non-small cell lung cancer (aNSCLC): A real-world study-Illumina in partnership with Syapse are presenting an abstract from a study assessing advanced Non-Small Cell Lung Cancer (aNSCLC) patients.

Recently announced CGP collaborations

Illumina continues to expand its broad portfolio of oncology partnershipswith industry leaders, aimed at advancing cancer diagnostics and precision medicine. Most recently, in collaboration with Bayer, Illumina launched the first companion diagnostic claim for the TruSightTM Oncology Comprehensive (EU) test enabling targeted therapy with Bayer's VITRAKVI (larotrectinib) for patients with NTRK fusion cancer. Also recently announced was a collaboration with Allegheny Health Network to evaluate the impact of in-house comprehensive genomic profiling (CGP) to enhance patient care.

"There is growing engagement and awareness around CGP and we will work with our partners to continue expanding the evidence to help broaden reimbursement and drive awareness across provider communities for this testing," said Dr. Febbo. "We are fully committed to improving outcomes by enabling personalized cancer care through genomics."

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more,visitwww.illumina.comand connect with us onTwitter,Facebook,LinkedIn,Instagram, andYouTube.

Investors:Salli Schwartz858.291.6421[emailprotected]

Media:Adi Raval US: 202.629.8172[emailprotected]

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SOURCE Illumina, Inc.

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Illumina to showcase the transformational impact of comprehensive genomic profiling in unlocking precision medicine for cancer patients, at ASCO -...

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Gene Editing Service Market Report 2022-2028 | Keyplayers- Caribou Biosciences, CRISPR Therapeutics, Merck KGa, Editas Medicine The Greater...